Device recall
Z-1953-2018: Sternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR…
FDA device recall · Class II · Genesee BioMedical, Inc.
Key facts
| Recall number (Z-number) | Z-1953-2018 |
|---|---|
| Recall event | 80024 |
| Product | Sternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR, SRLP-1, SRLP-AR, ATR-1, ATR-AR, CSR-1 and CSR-AR. For use in cardiac surgery. |
| Product code | DWS |
| Recalling firm | Genesee BioMedical, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 1000517719 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database